Clinical Trial of Safety and Clinical Efficiency of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Materia Medica Holding
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01843842
First received: April 26, 2013
Last updated: July 25, 2014
Last verified: April 2013
  Purpose

The purpose of this study is:

  • to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;
  • to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.

Condition Intervention Phase
Acute Upper Respiratory Tract Infections
Drug: Ergoferon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficiency of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

Resource links provided by NLM:


Further study details as provided by Materia Medica Holding:

Primary Outcome Measures:
  • Proportion of patients demonstrating recovery/improvement in health [ Time Frame: On day 2, 3 and 4 of observation ] [ Designated as safety issue: No ]
    Based on the data mentioned in a patient's diary


Secondary Outcome Measures:
  • Dynamics of fever [ Time Frame: Changes in body temperature on day 2, 3, 4 and 5 of observation in comparison with the baseline ] [ Designated as safety issue: No ]
  • Proportion of patients with normal body temperature (≤37.0ºС) [ Time Frame: On day 2, 3, 4, 5 of observation ] [ Designated as safety issue: No ]
  • Severity of clinical manifestations of acute respiratory infection (general symptoms and nasal/ throat/ chest symptoms) in scores [ Time Frame: On days 2-5 of observation ] [ Designated as safety issue: No ]
    On day 3rd of observation based on the results of objective examination conducted by a physician; on days 2-5 - based on data mentioned in a patient's diary

  • Duration of major clinical symptoms of acute respiratory infection (fever, general symptoms and nasal/ throat/ chest symptoms) in days [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Based on data mentioned in a patient's diary

  • The severity of acute respiratory infection course [ Time Frame: On day 1, 2, 3, 4, 5, 6 of the treatment ] [ Designated as safety issue: No ]
    Based on the data on area under curve for total index of severity of general symptoms and nasal/ throat/ chest symptoms on day 1, 3, 6 of observation - based on the results of objective examination conducted by a physician; on day 1, 2, 3, 4, 5 of the treatment - based on data mentioned in a patient's diary

  • Number of intakes of antipyretics if indicated [ Time Frame: On day 1, 2, 3, 4 and 5 of the treatment ] [ Designated as safety issue: No ]
    Based on data mentioned in a patient's diary

  • Proportion of patients with exacerbation of the disease course [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    The development of disease complications requiring antibiotics administration or hospitalization


Estimated Enrollment: 306
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergoferon (5 ml 3 times a day) Drug: Ergoferon
Safety and Efficiency of liquid dosage form
Placebo Comparator: Placebo (5 ml 3 times a day) Drug: Placebo
Safety and Efficiency of liquid dosage form

Detailed Description:

The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes aged over 3 years and under 18 years.
  2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
  3. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
  4. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
  5. Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.

Exclusion Criteria:

  1. Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
  2. Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
  3. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
  4. Medical history of sarcoidosis.
  5. Oncological diseases.
  6. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
  7. Medical history of polyvalent allergy.
  8. Allergy/ intolerance to any of the components of medications used in the treatment.
  9. Impaired glucose tolerance, diabetes mellitus.
  10. Hereditary fructose intolerance (as the study drug contains maltitol).
  11. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
  12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
  13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
  14. Mental disorders of patient or of patient's parents/adopters.
  15. Patient's parents/ adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  16. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
  17. Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  18. Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843842

Contacts
Contact: Mikhail Putilovskiy, MD, PhD +74952761575 ext 302 PutilovskiyMA@materiamedica.ru

Locations
Russian Federation
Municipal Institution "Child Health City Hospital №11" Completed
Ekaterinburg, Russian Federation, 620028
State Budgetary Educational Institution of Higher Рostgradual Education "Russian Medical Academy of Рostgradual Education" of Ministry of Health of Russian Federation Enrolling by invitation
Moscow, Russian Federation, 123995
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov" Recruiting
Moscow, Russian Federation, 119992
Contact: Natalia Geppe, MD, PhD, ScD, Professor         
Principal Investigator: Natalia Geppe, MD, PhD, ScD, Professor         
Pirogov Russian National Research Medical University Enrolling by invitation
Moscow, Russian Federation, 117997
Morozovskaya Child Health City Clinical Hospital Withdrawn
Moscow, Russian Federation, 119049
State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation Recruiting
Novosibirsk, Russian Federation, 630091
Contact: Elena Kondurina, MD, PhD         
Principal Investigator: Elena Kondurina, MD, PhD         
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5" Recruiting
Perm, Russian Federation, 614066
Contact: Olga Perminova, MD, PhD         
Principal Investigator: Olga Perminova, MD, PhD         
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of Ministry of Health of Russian Federation Enrolling by invitation
Rostov, Russian Federation, 344022
State Budgetary Educational Institution of Higher Professional Education "Saratov State Medical University named after V.I. Razumovsky" of Ministry of Health of Russian Federation Enrolling by invitation
Saratov, Russian Federation, 410012
St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region" Recruiting
St. Peterburg, Russian Federation, 193312
Contact: Nina Baltserovich, MD, PhD, ScD, professor         
Principal Investigator: Nina Baltserovich, MD, PhD, ScD, professor         
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44" Recruiting
St. Petersburg, Russian Federation, 192212
Contact: Olga Jiglinskaya, MD         
Principal Investigator: Olga Jiglinskaya, MD         
State Budgetary Health Care Institution "Сity Child Health Polyclinic №44" Recruiting
St. Petersburg, Russian Federation, 191144
Contact: Andrey Kamaev, MD, PhD         
Principal Investigator: Andrey Kamaev, MD, PhD         
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation Recruiting
St. Petersburg, Russian Federation, 194100
Contact: Anna Galustyan, MD, PhD         
Principal Investigator: Anna Galustyan, MD, PhD         
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation Completed
St. Petersburg, Russian Federation, 194100
State Health Care Institution "Child Health City Hospital №22" Recruiting
St. Petersburg, Russian Federation, 196650
Contact: Svetlana Laleko, MD         
Principal Investigator: Svetlana Laleko, MD         
Limited Liability Company "Alliance Biomedical-Russian group" Recruiting
St.Petersburg, Russian Federation, 194356
Contact: Svetlana Lazareva, MD         
Principal Investigator: Svetlana Lazareva, MD         
State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health Recruiting
Yaroslavl, Russian Federation, 150000
Contact: Irina Melnikova, MD, PhD         
Principal Investigator: Irina Melnikova, MD, PhD         
Sponsors and Collaborators
Materia Medica Holding
  More Information

No publications provided

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01843842     History of Changes
Other Study ID Numbers: MMH-ER-007
Study First Received: April 26, 2013
Last Updated: July 25, 2014
Health Authority: Russia: Ministry of Health of Russian Federation

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014